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Spectrophotometric Determination and Validation of Clotrimazole in Pharmaceutical Formulations

Archana S., G. Bhavani

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Journal of Pharmaceutical and Medicinal Chemistry 10(2):p 57-61, July - Dec 2024. | DOI: https://doi.org/10.21088/jpmc.2395.6615.10224.3

How Cite This Article:

Archana S., G. Bhavani, Spectrophotometric Determination and Validation of Clotrimazole in Pharmaceutical Formulations. J Pharmaceut Med Chem. 2024;10(2): 57-61.

Timeline

Received : October 10, 2024         Accepted : November 28, 2024          Published : December 25, 2024

Abstract

Aim: A simple, sensitive, and cost-effective spectrophotometric method has been developed and validated for the determination of clotrimazole in pharmaceutical formulations. Settings and Method: The method is based on the measurement of absorbance at a specific wavelength (250 nm) in a methanolic solution. The linearity, precision, accuracy, limit of detection (LOD), limit of quantitation (LOQ), and robustness were investigated according to ICH guidelines. Results: The proposed method showed excellent linearity in the range of 1-25 µg/mL with a correlation coefficient (r) of 0.9998. The results indicated that the method is suitable for routine quality control analysis of clotrimazole in bulk and tablet formulations. Conclusion: The method is validated according to ICH guidelines and all the parameters are under the limits and used for routine analysis labs.


References

  • 1.   International Conference on Harmonization (ICH). Validation of Analytical Procedures: Text and Methodology Q2(R1). ICH Harmonized Tripartite Guideline, 2005.
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  • 3.   United States Pharmacopeia (USP). (2023). Clotrimazole, Monograph. USP.
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  • 7.   Shah, N. P., & Patel, N. M. (2015). Simultaneous estimation of clotrimazole and betamethasone dipropionate in pharmaceutical formulations by RP-HPLC. International Journal of PharmTech Research, 8(2), 235-240.
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  • 9.   Srinivasan, S., & Gopinath, G. (2017). Validation of HPTLC and UV spectrophotometric methods for determination of clotrimazole in pharmaceutical dosage forms. Journal of Pharmaceutical Analysis, 7(6), 358-366

Data Sharing Statement

There are no additional data available. All raw data and code are available upon request.

Funding

This research received no funding.

Author Contributions

All authors contributed significantly to the work and approve its publication.

Ethics Declaration

This article does not involve any human or animal subjects, and therefore does not require ethics approval.

Acknowledgements

We would like to express our gratitude to the patients, their families, and all those who have contributed to this study.

Conflicts of Interest

No conflicts of interest in this work.


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Cite this article

Archana S., G. Bhavani, Spectrophotometric Determination and Validation of Clotrimazole in Pharmaceutical Formulations. J Pharmaceut Med Chem. 2024;10(2): 57-61.


Licence:

Attribution-Non-commercial 4.0 International (CC BY-NC 4.0)

This license enables reusers to distribute, remix, adapt, and build upon the material in any medium or format for noncommercial purposes only, and only so long as attribution is given to the creator.


Received Accepted Published
October 10, 2024 November 28, 2024 December 25, 2024

DOI: https://doi.org/10.21088/jpmc.2395.6615.10224.3

Keywords

SpectrophotometryICH guidelinesValidation parameters

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Received October 10, 2024
Accepted November 28, 2024
Published December 25, 2024

licence


Attribution-Non-commercial 4.0 International (CC BY-NC 4.0)

This license enables reusers to distribute, remix, adapt, and build upon the material in any medium or format for noncommercial purposes only, and only so long as attribution is given to the creator.


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